Device recall
Z-0241-2023: GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to…
FDA device recall · Class II · Steris Corporation
Key facts
| Recall number (Z-number) | Z-0241-2023 |
|---|---|
| Recall event | 91020 |
| Product | GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applications. MODEL #(s): G1110001 |
| Product code | GEI |
| Recalling firm | Steris Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 28, 2024 |
| 510(k) numbers | K192265 |
| FEI number | 1527821 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database